510(k) K222608
- Device
- Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
- Applicant
- Tuttnauer , Ltd.
- 510(k) number
- K222608
- Product code
- FLE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-16
- Date received
- 2022-08-29
- Regulation
- 880.6880
- Classification name
- Sterilizer, Steam
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Robert Basile
- Address
- Har-Tuv Industrial Zone Beit-Shemesh IL 9910101 9910101
FDA Registration Numbers
- 3005899764
- 1220246
- 8030087
- 1926681
- 3015729
- 3010653034
- 3016777357
- 3010446656
- 1523530
- 3015207155
- 3023861999
- 3009685834
- 3022516928
- 1219189
- 9610612
- 2518157
- 2126663
- 3015231789
- 8043629
- 2916714
- 3002579136
- 3005544459
- 3030597797
- 2435367
- 3005180920
- 3038718579
- 1036362
- 3027434168
- 8010652
- 1825014
- 3025308469
- 1017522
- 3001061128
- 3016851379
- 3006610845
- 3013596742
- 3012068831
- 3044322716
- 3008110533
- 3013176080
- 3003934980
- 3010684578
- 3008342949
- 3011824442
- 3011421558
- 3010331645
- 3035366890
- 3013300766
- 3012421607
- 3007515605
- 3018815412
- 9680353
- 1932355
- 3017125427
- 3003947740
- 3007279848
- 3015376465
- 3031563141
- 3009519707
Source Documents
Other 510(k) Records For Product Code FLE
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| K232485 | AMSCO 600 Steam Sterilizer | Steris | 2023-09-13 |
| K231489 | Sturdy Autoclave Super Microm | Sturdy Industrial Co., Ltd. | 2023-06-21 |
| K223858 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | 2023-05-05 |
| K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | 2023-02-10 |
| K213545 | Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 | Steelco S.P.A. | 2023-02-02 |